Attorney General Josh Stein Takes Opioid Manufacturer Insys to Court

(RALEIGH) Attorney General Josh Stein today filed a lawsuit against drug manufacturer Insys Therapeutics, Inc. alleging an extensive scheme involving kickbacks, deception and fraud in marketing its drug Subsys. Subsys is a spray form of the synthetic opioid fentanyl, which is approximately 50 times stronger than heroin and 100 times more potent than morphine.

“As millions of Americans were becoming addicted to and dying from prescription painkillers, it appears Insys and its sales representatives pushing its incredibly potent opioid on North Carolina patients just to make more money,” said Attorney General Stein. “This is unconscionable, it’s unacceptable and it’s illegal. Today, I am acting to hold them accountable.”

Subsys is approved only for adult cancer patients who are already on round-the-clock opioids for pain, but experience additional, breakthrough pain and for whom no other pain medications are effective.

Dr. Christopher Grubb, a Greenville, North Carolina pain specialist who lectures on behalf of the NC Medical Board and numerous state medical societies, said, “The fentanyl in the Subsys drug delivery system is extremely addictive due to its very quick absorption into the bloodstream and its immediate euphoric effects. Subsys can also cause fatal respiratory depression if the patient hasn't developed a tolerance to round-the-clock opioids. Therefore, marketing Subsys for anyone other than those with terminal cancer needlessly puts patients at risk for unintentional overdose and drug addiction.”

The lawsuit alleges that Insys gave illegal kickbacks to doctors for promoting and prescribing Subsys for non-cancer patients, including through a multi-million dollar speaker program that rewarded physicians who wrote prescriptions for the drug. In 2012, a Charlotte-based Vice President of Sales told one sales rep, “They do not need to be good speakers, they need to write a lot of [Subsys prescriptions.]” This speaker program included an Insys-sponsored presentation at a headache clinic in Chapel Hill, during which a speaker pushed Subsys to headache specialists.

Insys employees also pushed doctors to switch patients who were being prescribed non-equivalent fentanyl prescriptions to Subsys, and often at a starting dose of up to twelve or sixteen times larger than the label directed.

Finally, the suit alleges that Insys deceived health insurers into covering Subsys prescriptions. Insys employees often posed as prescribers or their staff and invented medical histories for patients to ensure the drug would be covered. Only about 10 percent of prescriptions for which Insys sought prior authorization from insurers were for patients with breakthrough cancer pain, the only use the FDA had approved.